Protocol summary
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Study aim
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Evaluation of the effects of Ginger on clinical symptoms and laboratory signs in patients with COVID-19
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Design
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A phase 3, Placebo-controlled, Paralleled, double-blind, randomized clinical trial, 84 patients, randomized using blocks
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Settings and conduct
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This study will be conducted at the Shahid Mohammadi Hospital, Hormozgan University of Medical Sciences, Bandar Abbas.The study population is 84 patients with COVID-19 (42 patients in control group and 42 in study group).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging, age ≥18 years, primary clinical symptoms, non-hospitalized mild, and signing informed consent.
Exclusion Criteria: Patients with underlying diseases, includingchronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, and peptic ulcers, use of anticoagulant drugs like warfarin, and hormonal drugs, history of allergy to ginger, and pregnancy and breastfeeding
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Intervention groups
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Group A will be patients receiving standard treatment of COVID-19 according to the Ministry of Health's protocol. Group B will be patients receiving, in addition to the standard treatment, a ginger-based herbal tablet, at a dose of 1000 mg three times a day for a period of seven days.
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Main outcome variables
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Checking the SARS-CoV-2 clearance, improvement of fever
Evaluation of white blood cell count
Requremet for hospital admission
Occurrence of adverse drug reactions
General information
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Reason for update
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Moderate patients take many antivirals and other drugs that might interact with Ginger preparations. Moreover, the process of patient recruitment was very slow considering eligibility criteria.
Hence, the protocol of the trial updated in eligibility criteria, intervention, and outcomes for outpatients with Covid-19.
This trial was also conducted on outpatients (mild) with COVID-19, instead of inpatients (moderate).
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200506047323N1
Registration date:
2020-05-23, 1399/03/03
Registration timing:
prospective
Last update:
2021-10-29, 1400/08/07
Update count:
1
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Registration date
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2020-05-23, 1399/03/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-11-21, 1399/09/01
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Expected recruitment end date
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2021-02-19, 1399/12/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of Ginger on clinical manifestations and paraclinical features of patients with COVID-19: A randomized double-blind placebo-control clinical trial
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Public title
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The effects of Ginger in treatment COVID-19
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Age ≥18 years
Positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging
Primary clinical symptoms
Hospitalized
Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm
Exclusion criteria:
Underlying diseases, including chronic hepatitis, cirrhosis, cholestatic liver diseases, cholecystitis, and peptic ulcers
Use of anticoagulant drugs like warfarin, and hormonal drugs
History of allergy to ginger
Pregnancy and breastfeeding
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Age
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From 18 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
84
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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The medication and placebo will be coded by the project manager. Patients will be randomly allocated within the blocks based on the hidden codes, and study participants, physicians, and nurses who evaluate the outcomes will be blind to the intervention and studied groups.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-05-20, 1399/02/31
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Ethics committee reference number
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IR.HUMS.REC.1399.130
Health conditions studied
1
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Description of health condition studied
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COVID-19 disease
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ICD-10 code
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U07.2
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ICD-10 code description
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COVID-19, virus not identified
Primary outcomes
1
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Description
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SARS-CoV-2 clearance
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Timepoint
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Before intervention and day 7
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Method of measurement
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PCR test
2
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Description
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fever
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Timepoint
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Before intervention and daily during the study
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Method of measurement
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Thermometer
3
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Description
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White blood cell count
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Timepoint
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Before intervention and day 7
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Method of measurement
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Labratory
Secondary outcomes
1
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Description
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Hospital admission
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Timepoint
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During the intervention
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Method of measurement
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Questionnaire
2
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Description
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Incidence of serious adverse events
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Timepoint
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Before intervention and daily during the study
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Method of measurement
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Questionnaire
Intervention groups
1
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Description
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Intervention group: The standard treatment regimen for COVID-19 along with a Ginger-based herbal medicine (Vomigone 500 mg tablets, registration number: 9406633051781240, Dineh Iran Pharmaceutical Company) at a dose of 1000 mg three times a day for a period of seven days
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Category
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Treatment - Drugs
2
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Description
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Control group: The standard treatment for COVID-19 based on the Ministry of Health's protocol including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 200 mg twice a day for a period of seven days, along with a Vomigone-liked placebo tablets (Dineh Iran Pharmaceutical Company) at a dose of two tablets three times a day for a period of seven days
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Hormozgan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Information regarding the study outcomes will be shared.
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When the data will become available and for how long
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Data will become available after publication of obtained results
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To whom data/document is available
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Only academic institutions
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Under which criteria data/document could be used
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The study protocol or proposal should be approved by Ethics committee of institutions. The rights of authors and sponsors should be respected.
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From where data/document is obtainable
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M.fathalipour@yahoo.com
M.fathalipour@hums.ac.ir
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What processes are involved for a request to access data/document
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Requests should be addressed to the Technology and Research Vice-chancellery of Hormozgan University of Medical Sciences and the project executor should informed.
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Comments
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